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Objective assessment of fesoterodine for overactive bladder with benign prostatic hyperplasia

Objective assessment of fesoterodine for overactive bladder with benign prostatic hyperplasia - Fesoterodine for OAB with BPH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010296
Enrollment
40
Registered
2013-07-01
Start date
2013-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder associated with benign prostatic hyperplasia

Interventions

Fesoterodine 4mg~8mg/day

Sponsors

Dept. of Urology, Kyoto University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Obtaining of written informed consent 2) Adult male, aged≥50 3) Prostate volume≥20ml 4) Before administration of alpha-1 blockers, IPSS≥8 and QOL score≥2 5) After 4-week of more administraion of alpha-1 blockers, OABSS≥3 and OABSS third question≥2

Exclusion criteria

Exclusion criteria: 1) Post-void residual≥50ml 2) Urinary retention 3) Prostate cancer, neurogenic bladder, urethral stricture, chronic prostatitis, urinary infection, urinary tract calculi, interstitial cystitis 4) Patients who are contraindicated for fesoterodine administration 5) Within 2 weeks before entry, administration of contraindicated agents or treatments

Design outcomes

Primary

MeasureTime frame
Change of maximal bladder capacity and detrusor pressure on voiding by fesoterodine administration

Secondary

MeasureTime frame
1) Changes of other parameters of urodynamic studies 2) Changes of parameters of questionnaires 3) Changes of parameters of frequency-volume charts 4) Safety 5) Ratio of increase of fesoterodine dose

Countries

Japan

Contacts

Public ContactMayumi Yagi

Kyoto University Graduate School of Medicine Urology

075-751-3337

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026